SOP for Labeling Dispensed Materials
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/004/2025 |
| Supersedes | SOP/Aerosol/004/2022 |
| Page No. | Page 1 of Y |
| Issue Date | 06/02/2025 |
| Effective Date | 16/02/2025 |
| Review Date | 06/02/2028 |
1. Purpose
This Standard Operating Procedure (SOP) outlines the procedures for labeling dispensed materials used in aerosol manufacturing. It ensures that all dispensed materials are correctly labeled with relevant product information, including batch numbers, expiration dates, and other necessary details, in compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
2. Scope
This procedure applies to all personnel involved in labeling dispensed materials for aerosol manufacturing at [Company Name]. It covers the procedures for labeling dispensed materials, including the required information, verification, and corrective actions in the event of labeling errors. This SOP does not apply to materials that have already been labeled or finished products.
3. Responsibilities
- Labeling Personnel: Responsible for ensuring that materials are labeled correctly and with the required information, as specified by the batch production instructions.
- Quality Control (QC) Team: Responsible for verifying that the labels meet the specified standards and that they are applied correctly to the dispensed materials.
- Warehouse Supervisor: Ensures that the materials are stored properly after labeling and that any labeling errors are promptly corrected.
- Production Personnel: Responsible for confirming that dispensed materials are correctly labeled before being used in the production process.
4. Accountability
The Production Manager is accountable for ensuring that this SOP is followed during the labeling of dispensed materials and that any deviations are addressed. The overall compliance to this SOP is under the supervision of the Quality Assurance (QA) Manager.
5. Procedure
5.1. Labeling of Dispensed Materials
- Upon dispensing, the material should be transferred to a designated labeling area. Ensure that the material is in the correct container and ready for labeling.
- Label the container with the required information, including but not limited to:
- Material Name
- Batch Number
- Quantity Dispensed
- Expiry Date
- Production Date
- Operator Name or Initials
- Ensure that all information is legible, correct, and free from errors. Labels must be clear and tamper-evident where required.
- If the material is subject to any specific storage requirements (e.g., temperature-controlled storage), include this information on the label as well.
5.2. Verification of Labels
- The QC team will verify the labeling of all dispensed materials to ensure that the labels are correctly applied and that all required information is included.
- Any discrepancies identified during verification (e.g., missing information, incorrect batch numbers, or expiry dates) must be documented, and the labels should be corrected immediately.
- Once verified, the materials should be stored according to the specified storage requirements.
5.3. Handling Labeling Errors
- If a labeling error is discovered, the incorrect labels must be removed and replaced with new, correct labels. A labeling error report must be completed to document the issue, including the cause of the error and the corrective actions taken.
- Materials with labeling errors should not be used in production until the issue has been resolved and verified by the QC team.
5.4. Corrective and Preventive Actions (CAPA)
- In the event of repeated labeling errors, a root cause analysis should be conducted to determine the underlying cause(s) of the problem.
- Corrective actions should be taken to address the immediate issue, such as retraining personnel, adjusting procedures, or updating equipment.
- Preventive actions should be implemented to ensure that future labeling errors are minimized, including process improvements, enhanced verification procedures, or more detailed labeling instructions.
6. Abbreviations
- GMP: Good Manufacturing Practice
- QC: Quality Control
- CAPA: Corrective and Preventive Actions
7. Documents
- Labeling Log (Annexure-1)
- Labeling Discrepancy Report (Annexure-2)
- Labeling Verification Log (Annexure-3)
8. References
This SOP is based on the following regulatory guidelines and industry standards:
- Good Manufacturing Practice (GMP) Guidelines
- FDA Code of Federal Regulations (CFR) Title 21, Part 211
- ISO 9001:2015 – Quality Management Systems
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Labeling Log
| Material Name | Batch No. | Labeling Date | Operator | Label Information |
|---|---|---|---|---|
| Example Material | 12345 | 06/02/2025 | Ravi Kumar | Batch No., Expiry Date, Quantity Dispensed |
Annexure-2: Labeling Discrepancy Report
| Discrepancy Description | Action Taken | Responsible Party | Resolution Date |
|---|---|---|---|
| Missing Expiry Date | New label applied | Ravi Kumar | 07/02/2025 |
Annexure-3: Labeling Verification Log
| Material Name | Batch No. | Verification Date | Verified By | Verification Result |
|---|---|---|---|---|
| Example Material | 12345 | 06/02/2025 | Rajesh Patel | Verified |
12. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By | Page No. | Ref. Point No. | Details of Revision |
|---|---|---|---|---|---|---|---|
| 01/01/2024 | V 1.0 | Initial Release | First Issue | Anjali Sharma | Page 1 | [Ref Point] | First Release |
| 01/01/2025 | V 2.0 | Updated labeling procedures and added corrective actions | To comply with updated GMP regulations | Anjali Sharma | Page 1 | [Ref Point] | Updated procedures |